Oct 19 2015
Pulsar Vascular, an innovative medical device company, focused on breakthrough technology in the neurovascular space, announced today that they have reached the target enrollment in their clinical trial for PulseRider®, the company's lead product. This multi-center study was conducted under an Investigational Device Exemption (IDE) granted by the U.S. Food and Drug Administration (FDA) at ten (10) centers of excellence nationwide. The Principal Investigator for the study, Dr. Alejandro Spiotta, Assistant Professor of Neurosurgery and Interventional Neuroradiology, at the Medical University of South Carolina has played an integral part in support and execution of this clinical trial.
PulseRider, is a medical device designed to address an unmet need in treating complex aneurysms of the brain, which can be life altering for patients if they rupture. Rob Abrams, the President and Chief Executive Officer of Pulsar Vascular said, "Completing enrollment of the clinical trial highlights an important milestone for the company. We now look forward to the next steps, which include patient follow-up and the analyses of data in support of PulseRider, which we anticipate will be reported to FDA early in 2016." Mr. Abrams also reported that, "We are delighted with our progress in Europe and Japan, treating these complex lesion."